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    Summary
    EudraCT Number:2020-000384-23
    Sponsor's Protocol Code Number:1434-0004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-03-28
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2020-000384-23
    A.3Full title of the trial
    A multicenter, randomized, double-blind, parallel group, placebo controlled study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of BI 764198 administered orally once daily for 12 weeks in patients with focal segmental glomerulosclerosis
    Estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos, controlado con placebo para evaluar la seguridad, tolerabilidad, farmacocinética y farmacodinámica de BI 764198 administrado por vía oral una vez al día durante 12 semanas en pacientes con glomeruloesclerosis focal segmentaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to test BI 764198 in people with a type of kidney disease called focal segmental glomerulosclerosis (FSGS).
    Un estudio para probar BI 764198 en personas con un tipo de enfermedad renal llamada glomeruloesclerosis focal segmentaria (GEFS)
    A.3.2Name or abbreviated title of the trial where available
    PoCP study in FSGS
    Estudio de prueba de concepto clínico en GEFS
    A.4.1Sponsor's protocol code number1434-0004
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBoehringer Ingelheim España S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBoehringer Ingelheim España S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointCT Disclosure & Data Transparency
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number93 404 51 00
    B.5.5Fax number93 404 55 80
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code BI 764198
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNone yet
    D.3.9.1CAS number *MASKED*
    D.3.9.3Other descriptive nameBI 764198
    D.3.9.4EV Substance CodeSUB195183
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code BI 764198
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNone yet
    D.3.9.1CAS number *MASKED*
    D.3.9.3Other descriptive nameBI 764198
    D.3.9.4EV Substance CodeSUB195183
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code BI 764198
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNone yet
    D.3.9.1CAS number *MASKED*
    D.3.9.3Other descriptive nameBI 764198
    D.3.9.4EV Substance CodeSUB195183
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Glomerulosclerosis
    Glomerulosclerosis
    E.1.1.1Medical condition in easily understood language
    Glomerulosclerosis
    Glomerulosclerosis
    E.1.1.2Therapeutic area Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067757
    E.1.2Term Focal segmental glomerulosclerosis
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objectives of this study are to investigate safety, tolerability, and the pharmacokinetic and pharmacodynamic profile of BI 764198 vs. placebo administered orally once daily for 12 weeks in patients with primary FSGS or with TRPC6 mutations causing FSGS.
    Los objetivos principales de este estudio son investigar la seguridad, la tolerabilidad y el perfil farmacocinético y farmacodinámico de BI 764198 frente a placebo administrado por vía oral una vez al día durante 12 semanas en pacientes con GEFS primaria o con mutaciones en TRPC6 que causan GEFS.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male and female patients 18 years to 75 years (both inclusive) of age on the day of signing informed consent.
    - Patients diagnosed with biopsy proven primary FSGS or documented TRPC6 gene mutation causing FSGS prior to screening visit.
    - Average UPCR ≥ 1500 mg/g based on two 24 hour urine samples collected at least 7 days apart at screening.
    - Completion of initial corticosteroid therapy course (if applicable) or discontinuation due to intolerance before entry to the trial.
    - If applicable, corticosteroid therapy (i.e. prednisone) of ≤15 mg/day or ≤30 mg on alternate days with stable dose for at least 2 weeks at randomization, with no plan to change the dose during the study.
    - Patients treated with ACE inhibitors, ARBs, finerenone, aldosterone inhibitors, or SGLT2 inhibitors should be on a stable dose for at least 4 weeks prior to screening visit with no plan to change the dose during the study.
    - Body Mass Index (BMI) of ≤ 40 kg/m2 at screening visit.
    - Women of childbearing potential (WOCBP) must be willing and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the informed consent form (ICF). Men must be willing and able to use condom if their partner is a WOCBP.
    - Pacientes de ambos sexos, de entre 18 y 75 años (ambos inclusive) el día de la firma del consentimiento informado.
    - Pacientes con diagnóstico de GEFS primaria confirmada por biopsia o mutación en el gen TRPC6 documentada que causa GEFS, antes de la visita de selección.
    - Promedio de CPCO≥ 1500 mg/g basado en dos muestras de orina de 24 horas recogidas con al menos 7 días de diferencia en la selección.
    - Finalización de la tanda inicial del tratamiento con corticosteroides (si corresponde) o suspensión del tratamiento debido a intolerancia antes de entrar en el ensayo.
    - Si corresponde, tratamiento con corticosteroides (es decir, prednisona) de ≤15 mg/día o ≤30 mg en días alternos con una dosis estable durante al menos 2 semanas al azar, sin intención de modificar la dosis durante el estudio.
    - Los pacientes tratados con inhibidores de la ECA, ARAs, finerenona, inhibidores de la aldosterona o inhibidores de SGLT2 deben recibir una dosis estable durante al menos 4 semanas antes de la visita de selección, sin intención de modificar la dosis durante el estudio.
    - Índice de Masa Corporal (IMC) ≤ 40 kg/m2 en la visita de selección.
    - Las mujeres con posibilidad de quedarse embarazadas (WOCBP) deben estar dispuestas y ser capaces de utilizar métodos anticonceptivos altamente eficaces según la directriz ICH M3 (R2); es decir, aquellos con una tasa de ineficacia baja, inferior al 1% al año, cuando se utilicen correctamente y de forma sistemática. En el formulario de consentimiento informado (CI) se proporciona una lista de métodos anticonceptivos que cumplen estos criterios. Los hombres deben estar dispuestos a usar preservativo y ser capaces de hacerlo si su pareja es una mujer con posibilidad de quedarse embarazada (WOCBP).
    E.4Principal exclusion criteria
    - Known monogenic (with the exception of TRPC6 gene mutations) or clinical or histologic evidence of secondary FSGS.
    - Documented Alport syndrome, Nail Patella syndrome, diabetic nephropathy, IgA nephropathy, lupus nephritis, or monoclonal gammopathy (e.g., multiple myeloma).
    - Concomitant use of calcineurin inhibitors.
    - Concomitant treatment with cytotoxic agents (cyclophosphamide, chlorambucil), or CD20 monoclonal antibody, e.g., rituximab, within 5 half-lives before screening visit. Note: use of other immunosuppression therapies considered as standard of care may be allowed as long as the patient remains on stable therapeutic dose throughout the study.
    - Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 (CKD EPI formula based on serum creatinine and cystatin C) at screening visit.
    - Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >3X the upper limit of normal (ULN) at screening visit.
    - QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant ECG findings (at the investigator’s discretion) at screening visit.
    - Detection of graded cataract by LOCS III higher than NC1/NO1, C0, P0 in the slit lamp eye examination at screening visit. Planned cataract surgery during participation in the study. Patients with cataract who have undergone lens replacement are not excluded.
    - Women who are pregnant, nursing, or who plan to become pregnant while in the study.

    Further criteria apply.
    - Signos histológicos, clínicos o monogénicos (con excepción de la mutación en el gen TRPC6) conocidos de GEFS secundaria.
    - Síndrome de Alport, síndrome onicorrotuliano, nefropatía diabética, nefropatía por IgA, nefritis lúpica o gammapatía monoclonal (p.ej. mieloma múltiple) documentados.
    - Uso concomitante de inhibidores de la calcineurina.
    - Tratamiento concomitante con fármacos citotóxicos (ciclofosfamida, clorambucil), o con anticuerpos monoclonales anti-CD20 (p. ej., rituximab) dentro de las 5 semividas, antes de la visita de selección. Nota: Se puede permitir el uso de otros tratamientos de inmunosupresión considerados de referencia siempre que el paciente permanezca con una dosis terapéutica estable durante todo el estudio.
    - Tasa estimada de filtración glomerular (TFGe) < 30 mL/min/1,73 m2 (fórmula EPI de la ERC basada en la creatinina sérica y la cistatina C) en la visita de selección.
    - Alanina aminotransferasa (ALT)/aspartato aminotransferasa (AST) > 3 veces el límite superior de la normalidad (LSN) en la visita de selección.
    - Intervalos QTc (QTcF) superiores a 450 ms en varones o superiores a 470 ms en mujeres, o cualquier otro hallazgo clínicamente relevante del ECG (a discreción del investigador) en la visita de control.
    - Detección de cataratas graduadas por LOCS III superiores a NC1/NO1, C0, P0 en el examen ocular de la lámpara de hendidura en la visita de control. Cirugía de cataratas planificada durante la participación en el estudio. No se excluyen los pacientes con catarata que se hayan sometido a un reemplazo de lentes.
    - Mujeres embarazadas, lactantes o que planean quedarse embarazadas durante el estudio.

    Se aplican otros criterios.
    E.5 End points
    E.5.1Primary end point(s)
    1) Patients achieving at least 25% reduction in 24-hour urine proteincreatinine ratio (UPCR) relative to baseline (visit 3) at week 12.
    1) Pacientes que alcancen una reducción de al menos un 25% en el cociente de proteína/creatinina en orina (CPCO) de 24 horas respecto al valor inicial (visita 3) en la semana 12.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) 12 weeks
    1) 12 semanas
    E.5.2Secondary end point(s)
    1) Change in UPCR relative to baseline (visit 3) at weeks 4, 8, and 12
    2) Change in UPCR relative to screening at week 13
    3) Change in 24-hour urinary protein excretion relative to screening at week 12
    4) The following pharmacokinetic parameters of BI 764198 will be determined if feasible: - Steady state trough concentration Cpre,ss on week 4 and week 12
    1) Cambio en el CPCO respecto al valor inicial (visita 3) en las semanas 4, 8 y 12
    2) Cambio en el CPCO en relación con la selección en la semana 13
    3) Cambio en la excreción de proteínas en orina de 24 horas en relación con la selección en la semana 12
    4) Si es posible, se determinarán los siguientes parámetros farmacocinéticos del BI 764198:
    - Concentración mínima en estado estacionario Cpre,ee en la semana 4 y en la semana 12
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) weeks 4,8, and 12
    2) week 13
    3) week 12
    4) weeks 4 and 12
    1) semanas 4, 8 y 12
    2) semana 13
    3) semana 12
    4) semanas 4 y 12
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    United States
    Belgium
    France
    Germany
    Hungary
    Ireland
    Italy
    United Kingdom
    Spain
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days24
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Trial Investigator will advise the patient on future treatment and care after the patient's participation ends in this study.
    El investigador del ensayo asesorará al paciente sobre el tratamiento y la atención futuros una vez que la participación del paciente finalice en este estudio.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-05-09
    P. End of Trial
    P.End of Trial StatusOngoing
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